Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology

NCT04531241 | Completed Results FDA Device

• 1 other identifier: CR-6417
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 7

Brief Summary

This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Overall CLUE Comfort

  Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

  1-Week Follow-up

• Overall CLUE Vision

  Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

  1-Week Follow-up

Secondary Outcomes (2)

• Visual Performance

  1-Week Follow-up

• Average Daily Wear Time (in Hours)

  1-Week Follow-up

Study Arms (2)

Test/Control

EXPERIMENTAL

Eligible subjects that are habitual wearers of daily disposable contact lenses in both eyes will be randomly assigned to sequence, Test/Control.

Device: ACUVUE® OASYS 1-DAY

Control/Test

EXPERIMENTAL

Eligible subjects that are habitual wearers of daily disposable contact lenses in both eyes will be randomly assigned to sequence, Control/Test.

Device: ACUVUE® OASYS 1-DAY

Interventions

ACUVUE® OASYS 1-DAY DEVICE

senofilcon A contact lenses made with a novel manufacturing technology

Also known as: TEST

Control/Test; Test/Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
• The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes (at least 1 month of daily wear).
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).
• The subject's required spherical contact lens prescription must be in the range of -0.50 to -3.25 and -3.75 to -6.00 D in each eye.
• The subject's refractive cylinder must be ≤0.75D in each eye, if present
• The subject must have best corrected visual acuity of 20/25 or better in each eye.

You may not qualify if:

• Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
• Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. (at the discretion of the investigator)
• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Monovision or multi-focal contact lens correction.
• Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
• History of binocular vision abnormality or strabismus.
• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
• Suspicion of or recent history of alcohol or substance abuse.
• History of serious mental illness.
• History of seizures.
• Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
• Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion
• Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Food and Drug Administration (FDA) classification scale.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (7)

Vue Optical Boutique

Jacksonville, Florida, 32205, United States

Location

Maitland Vision Center

Maitland, Florida, 32751, United States

Location

Tallahassee Eye Center

Tallahassee, Florida, 32308, United States

Location

VisionPoint Eye Center

Bloomington, Illinois, 61704, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

EyeCare Professionals of Powell

Powell, Ohio, 43065, United States

Location

Frazier Vision, Inc.

Tyler, Texas, 75703, United States

Location

Results Point of Contact

• Title: Meredith Bishop, OD, MS, FAAO
• Organization: Johnson & Johnson Vision Care, Inc.

mbishop4@its.jnj.com

1-800-843-2020

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 28, 2020
• Study Start: August 5, 2020
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2020
• Last Updated: December 14, 2021
• Results First Posted: December 14, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

US (7)